The United States Food and Drug Administration says the shortage of Eli Lilly’s Zepbound and Mounjaro drugs has been resolved and that specialty pharmacies and online companies need to stop selling off-brand versions of the weight-loss drugs.
The FDA has issued warnings against the off-brand versions, citing safety concerns.
“FDA is aware that some patients and health care professionals may look to unapproved versions of GLP-1 drugs, including semaglutide and tirzepatide, as an option for weight loss,” the FDA said last week. “This can be risky for patients, as unapproved versions do not undergo FDA’s review for safety, effectiveness and quality before they are marketed.”
The FDA recommended patients obtain drugs with “a prescription from their doctor and fill the prescription at a state-licensed pharmacy.”
Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a letter last week that the demand for Zepbound and Mounjaro is being met, negating the need for the off-brand versions.
“We conclude that the information and data Lilly has provided to FDA demonstrate that Lilly’s supply is currently meeting or exceeding demand for these drug products and that Lilly has developed reserves that it now holds in its finished product inventory, plus significant units of semi-finished product, and has scheduled substantial additional production over the coming months, such that supply will meet or exceed projected demand,” she said.
What does the FDA decision mean?
GLP-1 class drugs like Zepbound and Mounjaro form part of a larger group of products like Wegovy and Ozempic from Novo Nordisk that have shown results in helping people lose weight.
With demand for these drugs skyrocketing, telehealth and compounding pharmacies like Hims and Ro began to offer off-brand and cheaper versions of Zepbound and Mounjaro.
According to the press release from the FDA, businesses will have between 60 and 90 days, depending on their size to stop the distribution of their off-brand products.
The FDA’s decision is a win for Lilly, the drug’s manufacturer, according to the Associated Press, prices and ways to access drugs like Zepbound and Mounjaro could be affected as a result of the move.
What are Zepbound and Mounjaro?
Both drugs have been approved by the FDA, with Zepbound being approved to treat obesity and Mounjaro being approved for diabetes. Although for different uses, both drugs have the same active ingredient which is tirzepatide.
Fernando Cervantes Jr. is a trending news reporter for . Reach him at [email protected] and follow him on X @fern_cerv_.
